Clear Observation

Can clinical trial costs and time to completion be reduced by adopting
supply chain visibility tools? Experience shows us that they can, but
uptake appears to still be relatively low. So what are the barriers
preventing wider usage of supply chain visibility tools and how can they
be overcome in practice?

A reliable supply chain can make or break the success of a clinical
trial, but why isn’t maximising efficiency a focus for many
pharmaceutical companies? Ensuring patient enrolment is, of course, a
more pressing concern than the inventory, and this can lead to
sacrificing efficiency and flexibility in the supply chain in order to
minimise the risk of not having the treatment available at the
investigator site when needed. Also, many companies are under the
misconception that implementing a more responsive supply chain will
require a significant investment in terms of time and money that will
not deliver the expected benefits.

In the first instance, the supply chain might not be considered a hugely
important factor in clinical trials success, but when you start to
consider the huge costs involved in moving investigational medicines
across the globe, and the need to account for all returns to complete
the trial, it is possible to appreciate how a supply chain that isn’t
operating at maximum efficiency can result in clinical trials taking
longer and costing more than they need to. In this case, any technology
which can claim to make significant cuts to the time and money spent on
clinical trials demands closer investigation.

Supply chain visibility tools are one such technology. Implementation of
these tools can return significant reductions in both study duration
and costs. Based on previous experiences, reductions to distribution
costs by 50 per cent and inventory costs by 40 per cent are typical when
visibility tools are used in conjunction with network optimisation.
However, research has shown that the uptake of this technology has been
slower than expected among pharmaceutical and biotechnology companies
within their clinical trial programmes. Research also suggests that the
reasons for this are largely built on misconceptions regarding the
difficulty and costs involved in implementing these tools and the
complexity of using them. Given the potential return on investment
involved, it’s time that the decision makers within clinical trial
functions looked again and asked themselves whether they are really
getting everything that they need from their supply chains in order to
compete.

What is Supply Chain Visibility?

Supply chain visibility is the ability to know at any one time the
location and status of the total clinical trial inventory – where all
supplies of the medicines under investigation are, approximate timings
to move them throughout the supply chain and additional information,
such as how they are packaged or labelled and when they are due to
expire. This can include investigational medication, returns,
ancillaries and lab kits, although the focus of this article is
medication.

Why is this Important in the Clinical Trial Setting?

The benefits of improved visibility are a more responsive supply chain,
especially important in a clinical trial setting with limited supplies
of experimental stock, as well as the critical importance of having
enough to meet supply in various locations. Clinical trials are critical
for the ongoing success of any innovative pharmaceutical or
biotechnology company, and it is perfectly understandable that companies
feel that getting the supply chain to operate at maximum efficiency is
not as high a priority as other aspects of the clinical trial programme.
Instead, the most important concern is making sure that investigational
medicines or treatments get to patients when they are needed. In order
to ensure that this happens, clinical trial supply chains are often
‘front-loaded’; that is, a lot of stock will be pushed through to the
end of the chain without a clear idea of how much is actually required.

The end result of this approach is that the supply chain becomes bloated
and inefficient. It takes longer to respond to changes in demand, and
it takes longer for unused stock to be returned or redeployed, thus
increasing the associated costs. Often this results in additional
manufacturing/packaging activities, increasing overall cost further.

This is often seen as a small price to pay in order to ensure that the
trial runs to protocol and timelines, and is accepted as a necessary
evil. While in the past this may have been the case, these days updated
technologies allow us to be much more sophisticated and get our supply
chains to work harder and smarter. Research shows that the benefits of
supply chain visibility are well understood. So why are they not being
used as much as we would expect? Research commissioned by DHL and
conducted by the agency FreshMinds looked into why pharmaceutical and
life sciences companies were not using these tools more in clinical
trials, and three key themes emerged:

Concerns around data collection – information related to the
supply chain may be collected in different ways and at different levels
meaning that confidence in any system being able to offer true
visibility is low

Inefficient working practices – the theoretical benefits of supply
chain visibility are thought to be unobtainable in practice due to
realities on the ground, including the sheer number of stakeholders

The misconception that the technology is expensive – aligned to
this is the belief that, although inefficient, current processes are
functioning adequately enough and there’s no great urgency to improve
them All of these are reasonable concerns although, as the case studies
demonstrate, we have seen companies implement these tools and make real
cost and time savings. So how have they done it?

Simple Steps to Success

The simple truth is that some ways of doing things will have to change
if the benefits of supply chain visibility tools are to be realised in a
clinical trials setting. This doesn’t have to be a huge undertaking,
and the simple steps listed below might help companies to consider how
they could benefit from upgrading their clinical trial supply chains.

Move Towards a Standardised Method of Data Collection

This isn’t as painful as it sounds. Most clinical trial supply chains
involve a lot of logistical data being generated, collected and used.
For example, data regarding transport management systems, warehouse and
order management systems and so on, is all generated. The data received
centrally is only ever as good as the data captured locally, and so if
this is not being done in an optimal way, there are clear limits over
what can be achieved in terms of supply chain visibility, flexibility
and responsiveness.

If current systems are using disparate information capture systems,
consider switching to a standardised model. A good example is using
online forms to capture information across the supply chain, which can
then be collected in one place and converted into an easy-to-read
format. As soon as you show people that data can be aggregated in one
place, then see the benefits this could bring.

Improve Communication Between Teams

This will help them to learn from each other. It’s easy to lose sight of
the number of stakeholders involved in clinical trials and how
disparate they can be. Modern clinical trial programmes taking place in
many countries involve a lot of people working together from around the
world, which can make managing an efficient supply chain a real
challenge.Different decisions made at different locations can affect the
overall supply chain. Regular communication between teams is essential
if any lessons learnt are to be shared during the trial rather than at
the end, or even worse, not shared at all. Supply chain managers should
be involved at all stages of the process to ensure that important
logistical needs, including customs and regulatory issues, are not
overlooked.

Expect More from your Supply Chain

Time and money invested in making the supply chain more efficient is
likely to see significant returns. As more companies adopt supply chain
visibility tools, the benefits, become more apparent. Companies have
seen a concrete return on investment and increased flexibility when they
have upgraded their clinical trial supply chains. Taking a view of the
industry and the competitive nature of healthcare technology research,
it is very likely that supply chain visibility technology in clinical
trials will have become the norm by 2015, rather than the exception that
it is today.

Further reading

Selected case studies and the findings from the research carried out by
FreshMinds can be accessed at www.dhlsupplychainexperts.
com/home/life-sciences

Jonathan Blamey is Vice President of Global Product and Account Leader
for DHL Supply Chain’s Life Sciences and Healthcare sector. In his
current role, Jonathan is responsible for global clinical trials and
hospital logistics expansion. He has worked for DHL Supply Chain in
various positions since 2004, serving as Vice President of Product
Development for the Technology and Healthcare sectors and General
Manager of Clinical Trials Logistics, before taking on his current role
in 2007. Jonathan holds a PhD in Biomedical Engineering from the
University of Durham. He has also completed an MBA at Lancaster
University and holds an MSc in Materials Science and a BSc in
Engineering.

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